Reported May 20, 2015 · Terminated
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2…
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
- Lot codes and dates
39 of 39 products
Products covered by this recall # Product as published 1 lot 287303120, 02-APR-15 2 lot 287303122, 02-APR-15 3 lot 287306710, 08-MAY-15 4 lot 287308210, 23-MAY-15 5 lot 287311710, 27-JUN-15 6 lot 287314910, 29-JUL-15 7 lot 287314912, 29-JUL-15 8 lot 287315710, 06-AUG-15 9 lot 287317310, 22-AUG-15 10 lot 287317710, 26-AUG-15 11 lot 287318920, 07-SEP-15 12 lot 287319110, 09-SEP-15 13 lot 287319820, 16-SEP-15 14 lot 287321940, 07-OCT-15 15 lot 287322540, 13-OCT-15 16 lot 287323520, 23-OCT-15 17 lot 287324220, 30-OCT-15 18 lot 287324240, 30-OCT-15 19 lot 287326220, 19-NOV-15 20 lot 287327620, 03-DEC-15 - Amount recalled
- 43,535/20-card cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
This product could cause temporary or reversible health problems — stop using it.
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